Length of Hospital Stay and Postoperative Analgesic Requirements After Introduction of a Specific Maxillary Nerve Block in Children Undergoing Cleft Palate Surgery

NCT ID: NCT07279883

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2025-12-31

Brief Summary

Cleft lip and palate (CLP) is one of the most common congenital malformations and requires repeated surgical correction during childhood. Surgical repair is often associated with significant postoperative pain, traditionally managed with morphine, which carries a risk of undesirable side effects. The suprazygomatic maxillary nerve block (SZMNB) has been shown to provide effective analgesia and may reduce the need for opioids.

Routine use of SZMNB was introduced at the pediatric surgery unit at Karolinska University Hospital in late 2017. A before-and-after evaluation project based on retrospective chart review was initiated in 2018 but was not completed due to the COVID-19 pandemic.

The aim of this project is to investigate whether the introduction of SZMNB has reduced postoperative morphine requirements and opioid-related side effects, and whether this has resulted in shorter hospital stays (earlier discharge) after cleft palate repair.

Detailed Description

Scientific background and rationale Cleft lip and palate (CLP) is one of the most common congenital malformations and often requires repeated surgical corrections during childhood. These procedures are associated with considerable postoperative pain that may delay recovery and prolong hospital stay. Traditionally, systemic analgesics (opioids, NSAIDs, and acetaminophen given intravenously or orally) have been used, but these are often insufficient or associated with adverse effects.

Peripheral nerve blocks have become an established and effective method to optimize pain control and reduce side effects in many surgical procedures. The suprazygomatic maxillary nerve block (SZMNB) is a well-described technique that can provide efficient analgesia in cleft palate surgery. Previous studies have demonstrated its safety and analgesic benefits.

Objectives and hypothesis The aim of this study is to evaluate the effectiveness and patient benefits of introducing routine SZMNB as an adjunct to standard analgesic therapy in children undergoing cleft palate surgery at Astrid Lindgren Children's Hospital, Karolinska University Hospital.

Hypothesis: SZMNB provides superior postoperative pain control and shorter hospital stay compared with conventional systemic analgesia alone.

Study design and methods This is a retrospective observational study based on chart review of patients aged 3 months-15 years who underwent cleft palate surgery at Astrid Lindgren Children's Hospital during 2017-2018. No intervention will be performed.

Data will be collected from medical records, including demographics (age, sex, weight), surgical procedure, perioperative and postoperative analgesic regimen (type, dose, timing), presence of SZMNB, pain scores when available, and any recorded adverse effects (nausea, sedation, etc.).

Outcome measures Primary outcome: Length of hospital stay, defined as time from arrival in the recovery unit to the time of discharge documentation.

Secondary outcomes: Total postoperative opioid consumption, need for supplemental analgesia, and frequency of opioid-related side effects (e.g., nausea, sedation).

Statistical analysis Pseudonymized data will be analyzed descriptively and comparatively using standard statistical methods. Results will be presented in tables and figures. Manuscript preparation and analysis will be conducted at Karolinska Institutet, and the results will be submitted for publication in a peer-reviewed journal.

Clinical significance Peripheral nerve blocks such as SZMNB may reduce opioid requirements, shorten hospital stay, and improve recovery in children after cleft palate surgery. This project aims to quantify these effects within our institution. Demonstrated benefits could support wider implementation of SZMNB, improve care efficiency, and enhance the quality of postoperative recovery for affected children.

Conditions

Cleft Palate Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pre-implementation group (2017)

Children who received standard systemic analgesia (intravenous and/or oral opioids, acetaminophen, and NSAIDs) without nerve block.

No interventions assigned to this group

Post-implementation group (2018)

Children who, in addition to standard systemic analgesia, received a suprazygomatic maxillary nerve block (SZMNB) as part of routine perioperative care.

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Jacob Karlsson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Märit Lundblad, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Jacob KarlssonM, MD PhD

Role: CONTACT

jacob.karlsson.1@ki.se

+460812370000

Facility Contacts

Märit Lundblad

Role: primary

marit.lundblad@regionstockholm.se

Other Identifiers

Dnr 2025-04058-01

Identifier Type: -

Identifier Source: org_study_id